MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA-1001

Device Problem Decrease in Suction (1146)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

Patient is a (b)(6) (b)(4) (7 total pregnancies, six deliveries and five living children) with a history of 3 prior cesarean sections and ultrasound that showed concern for potential focal placenta accreta in subject pregnancy.She presented to labor and delivery at 34 weeks and 6 days with preterm rupture of membranes.She began experiencing contractions and progressed from a cervical dilation of 1 to 2 cm.She was consented to a repeat cesarean section.During the surgery, a large hypervascular bulge, consistent with placental tissue under the bladder flap was observed.In order to avoid potentially abnormally adherent placenta during hysterotomy, a "classical" uterine incision was made and a 5 lb 13.1 oz infant was delivered at 12:39am on (b)(6) 2021.The placenta was then delivered with removal of the placental tissue from the defect in the scar from past cesarean.This left a roughly 3x3cm hole in the lower uterine segment (at the corner of the prior c-section scar)."figo 3a placenta acretta" was diagnosed.Pressure was held and the hysterotomy was repaired.Bleeding wasn't seen abdominally, but inspection showed ongoing vaginal bleeding.The dehisced area over her previous cesarean scar was repaired and noted to be very thin.Lower uterine segment atony was appreciated due to lack of myometrium and pitocin was increased and methergine administered.Jada was placed in severe pph (ebl at placement not noted but will have been over 2500 ml noted as ebl with the c-section and as such was a severe pph).A large amount of clot was evacuated from the vagina which had collected behind the cervix as her internal os was only 1cm and felt scarred from a prior leep procedure (procedure to remove cancerous cells from the cervix that can often leave a scarred cervix).Following jada device placement, bleeding decreased, and minimal blood was seen coming through the jada suction tubing.The uterus involuted (collapsed) appropriately with connection to vacuum.All abnormal bleeding stopped at this time.There was complete hemostasis abdominally and serial vaginal exams showed no further bleeding from the vagina.Hemostasis was established and the patient was taken to the recovery room in stable condition.In recovery, blood was found pooling behind her cervix (but below the endometrium) (blood held back by scarred cervix due to previous leep), instead of draining down.Ultrasound showed thin endometrial stripe, but with clot in lower uterine segment behind the cervix.At bedside, evacuated 500cc of clot behind jada seal and in cervix.A few minutes later the nurse reported that jada was falling out of vagina.Device "easily slipped out" and "obviously clogged with clot and no longer on suction." jada was re-inserted (same device) and this time suction was evident and working.During the re-insertion, the clot from prior used tubing (the tubing connected to jada) was suctioned into canister and was measured to be 300cc.Ultrasound was repeated, and jada again visualized in thin endometrial stripe, with no clot in lower uterine segment behind the cervix.At this time, fundus confirmed firm and positioned appropriately below the umbilicus, indicating the uterus is becoming smaller.With the total ebl at this time noted as 3000 ml and concern for hemodynamic stability and possibility of ongoing bleeding from the accreta in the lower uterine segment, interventional radiology was paged for uterine artery embolization to address the bleeding risk in the area of hypervascular bleeding at the focal accreta.Complications of delivery included placenta accreta spectrum, triple i (chorioamnionitis), focal accreta at left lower uterine segment with loss of myometrium, almost in appearance of dehiscence.Physician note on post-op day 4 stated that "jada was removed on post-op day 1 with minimal bleeding since removal." total ebl for pph event: 4300 ml.Total products administered: 7 units packed red blood cells, 4 units fresh frozen plasma.Date of admission: (b)(6) 2021.Date of discharge: (b)(6) 2021.

Manufacturer Narrative

This use of jada involved a patient with a noted focal placenta accreta.The jada system labeling states: precaution: the safety and effectiveness of the use of jada in patients with placenta accreta have not been evaluated.The indications for use for the jada system are as follows: the jada® system is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.Treatment of placenta accreta typically involves more than conservative management.In this use of jada, care was escalated for the original diagnosis of postpartum hemorrhage, consistent with the device labeling.The device labeling statement related to reassessment and escalation is as follows: "warning: signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding." it is unclear whether the jada malfunctioned based on the information that is available at this time, but out of an abundance of caution and because we cannot rule it out at this time, we are reporting this event due to the 30-day reporting deadline.If we become aware of additional information, we will supplement this report.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• MDR Report Key: 11429587
• MDR Text Key: 280453025
• Report Number: 3017425145-2021-00002
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 03/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4 UNITS FRESH FROZEN PLASMA; 7 UNITS PACKED RED BLOOD CELLS; METHERGINE; PITOCIN; TRANEXAMIC ACID; UTERINE ARTERY EMBOLIZATION
• Patient Age: 40 YR
• Patient Weight: 68